MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR03, 5X100 KII OPT ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CFR03

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

This report is a follow-up report to medwatch (b)(4).The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: laparoscopic, repair of anterior abdominal hernia (epigastric, incisional, ventral, umbilical, spigelian), laparoscopic, intal, inc implntn of mesh when perf, tot len of def; 3 cm incarc or strang.Detailed description of event: complaint created based off medwatch report.Uf/importer report (b)(4), hair found on the trocar during sterile field setup.Product is available for return.Patient status: (no patient involvement).Type of intervention: the defect was identified prior to the start of the case, and the item was removed.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of hair.Based on the condition of the returned unit and the description of the event, it is likely that the hair originated from an operator and was packaged with the product during the manufacturing process.This report is to follow-up medwatch #(b)(4).

Event Description

Name of procedure being performed: laparoscopic, repair of anterior abdominal hernia (epigastric, incisional, ventral, umbilical, spigelian), laparoscopic, intal, inc implntn of mesh when perf, tot len of def; < 3 cm; incarc or strang detailed description of event: complaint created based off medwatch report.Uf/importer report # (b)(4).Hair found on the trocar during sterile field setup.Product is available for return.Patient stauts: ni (no patient involvement).Type of intervention: the defect was identified prior to the start of the case and the item was removed.

• Brand Name: CFR03, 5X100 KII OPT ADVFIX 6/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16825412
• MDR Text Key: 314121342
• Report Number: 2027111-2023-00428
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915119881
• UDI-Public: (01)00607915119881(17)251024(30)01(10)1468370
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CFR03
• Device Catalogue Number: 101221201
• Device Lot Number: 1468370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1